Search Results

PERI-GUARD is intended for repair of pericardial structures. PERI-GUARD is also intended for use as a patch for intracardiac defects, great vessel, septal defects and annulus repair, and suture-line buttressing.

SUPPLE PERI-GUARD is intended for use as a prosthesis for pericardial closure.

PERI-GUARD Repair Patch (PERI-GUARD) and SUPPLE PERI-GUARD Repair Patch (SUPPLE PERI-GUARD) are derived from bovine pericardium procured from cattle originating in the United States. The pericardium is crosslinked with glutaraldehyde and treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20-25°C (68-77°F).

PERI-GUARD and SUPPLE PERI-GUARD are terminally sterilized using gamma irradiation and packaged within a sterile double-pouch system. The contents of the unopened, undamaged outer pouch are sterile.

PERI-GUARD and SUPPLE PERI-GUARD are MR Safe.

PERI-GUARD and SUPPLE PERI-GUARD utilize animal tissue; patient must be informed prior to any procedure.

This is a 510(k) premarket notification for the PERI-GUARD Repair Patch and SUPPLE PERI-GUARD Repair Patch. This document describes the device, its intended use, and the performance data provided to demonstrate substantial equivalence to predicate devices. The submission focuses on changes to packaging and sterilization parameters, with a reliance on historical data for many performance aspects.

Here's the breakdown of the acceptance criteria and the study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" with numerical targets and corresponding "device performance" results for each criterion in the typical sense of a clinical or standalone performance study. Instead, it lists various performance tests conducted to support substantial equivalence. The "reported device performance" is implicitly that the devices "meet" or "demonstrate equivalence" to the predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify exact sample sizes for each performance test. It mentions "aging testing" for shelf life, but without a specific sample size. The studies are non-clinical (laboratory/bench testing, in vitro), not based on patient data. Therefore, questions about country of origin and retrospective/prospective nature are not applicable in this context.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. This is a submission for a medical device (a patch), and the evaluation is based on non-clinical performance data and substantial equivalence to existing devices, not on diagnostic accuracy against a "ground truth" established by human experts.

4. Adjudication Method for the Test Set

Not applicable. See point 3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

Not applicable. This is a physical medical device, not an AI/software as a medical device (SaMD) that involves human readers or AI assistance.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This is a physical medical device, not an algorithm or AI.

7. The Type of Ground Truth Used

Not applicable in the context of diagnostic accuracy. For the performance tests listed, the "ground truth" or reference standards are the established industry standards, test methodologies (e.g., ASTM, ISO), and the performance characteristics of the predicate devices. For example, for "Burst Strength," the "ground truth" would be the measurement obtained using a validated testing procedure, and the performance would be compared to that of the predicate.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable. This is a physical medical device, not an AI/ML algorithm.

Ask a specific question about this device

SUPPLE PERI-GUARD is intended for use as a prosthesis for pericardial closure.

PERI-GUARD is intended for repair of pericardial structures. PERI-GUARD is also intended for use as a patch for intracardiac defects, great vessel, septal defects and annulus repair, and suture-line buttressing.

SUPPLE PERI-GUARD is prepared from bovine pericardium which is cross-linked with glutaraldehyde. SUPPLE PERI-GUARD has been treated with 1 molar sodium hydroxide for 60-75 minutes at 20-25°C. SUPPLE PERI-GUARD is terminally sterilized using gamma irradiation.

SUPPLE PERI-GUARD is packaged between two pieces of foam within a double sterile barrier pouch system. The contents of the unopened, undamaged package are sterile.

PERI-GUARD is prepared from bovine pericardium which is cross-linked with glutaraldehyde. PERI-GUARD has been treated with 1 molar sodium hydroxide for 60-75 minutes at 20-25°C. PERI-GUARD is terminally sterilized using gamma irradiation.

PERI-GUARD is packaged between two pieces of foam within a double sterile barrier pouch system. The contents of the unopened, undamaged package are sterile.

The provided document is a 510(k) premarket notification for two devices: SUPPLE PERI-GUARD Pericardium Patch and PERI-GUARD Repair Patch. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that the device meets specific acceptance criteria through a comparative effectiveness study with human readers or presenting detailed performance metrics.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study that proves the device meets those criteria in the context of AI or advanced clinical performance studies.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance in the format requested (likely due to the nature of a 510(k) submission not requiring explicit performance metrics in this way for equivalence).
• Any details about sample sizes used for a test set, data provenance, ground truth establishment, or expert involvement as typically found in studies for AI/diagnostic devices.
• Information on adjudication methods.
• A multi-reader multi-case (MRMC) comparative effectiveness study with effect sizes for human reader improvement with AI.
• A standalone (algorithm only) performance study.
• Sample sizes or ground truth establishment for a training set (as this is not an AI/machine learning device).

Instead, the document focuses on non-clinical testing to demonstrate safety and performance for substantial equivalence. The studies mentioned are:

1. Bench testing: Assessed aspects like suture retention, thickness, burst strength, ultimate tensile strength, collagenase digestion, chemical residuals, pyrogenicity/LAL, sterilization validation, and packaging/shelf-life. The document states, "Bench testing results support the performance requirements."
2. Biocompatibility testing: Performed in accordance with ISO 10993-1: 2009.
3. Animal studies: Conducted to support safety and efficacy.

These studies are conducted to show the new device is "substantially equivalent" to predicate devices, mainly due to changes in packaging and sterilization methods. The document repeatedly states that the devices (SUPPLE PERI-GUARD and PERI-GUARD) are acting as their own predicates.

Ask a specific question about this device